TerminatedNCT01775410COMBINEUpdated Apr 21, 2021Results posted

OptiCal COherence ToMography ABoard InformiNg AtherEctomy

An interventional study of Wolverine System to perform atherectomy in Atherectomy in Diseased Lower Extremity Arteries, sponsored by Avinger, Inc.. Terminated at 2 sites in Colombia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-04-21.

Sponsored by Avinger, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated

Study was terminated by sponsor without any AEs to review the device design.

Phase: Not applicable
Study type: Interventional
Enrollment: 4
Allocation: Not applicable
Ages: 18 Years to 100 Years
Sex: All

Study summary

This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities.The primary disease must be located in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention.

Read the detailed description

This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system. The trial is predominantly descriptive and, as such, not powered statistically although endpoint comparisons may be made to the published literature on peripheral atherectomy.

The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities. The primary disease must be located in reference vessel diameters ≥ 3.0 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention. Trial success is focused on short term safety including rates of major adverse events. An evaluation of efficacy will also be performed and will include an evaluation of technical success defined as the percent of target lesions that has a residual diameter stenosis \<50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate.

Conditions studied

Atherectomy in Diseased Lower Extremity Arteries

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age ≥ 18 years old.
Patient is a candidate for percutaneous intervention for peripheral vascular disease in the legs.
Patient is willing and able to give informed consent
Documented symptomatic atherosclerotic peripheral vascular disease Rutherford Classification 2-5.
Reference vessel lumen proximal to target lesion >2.5 mm in diameter by visual estimation.
Subject has de novo target lesion(s) with stenosis >70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Wolverine device.
Target lesion length \<10 cm if target lesion >70% and \<99% stenosed. If target lesion a chronic total occlusion (99-100% stenosed), target lesion length \<4 cm.
Patient is capable of meeting requirements and be present at the follow-up clinic visits at 30 days.
At least one patent tibial run-off vessel at baseline.

Exclusion criteria

Exclusion Criteria:

Subject is pregnant or breast feeding.
Rutherford Class 0 to 1 (asymptomatic and mild claudication).
Rutherford Class 6 (critical limb ischemia).
Severe calcification of the target lesion.
Target lesion with any type of stent or graft.
Target lesion in the iliac artery.
Target lesion stenosis \<70%.
Subjects with significant (>70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion.
Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure.
Planned endovascular or surgical procedure 30 days after the index procedure.
Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure.
Subjects with active infections whether they are being currently treated or not.
Hemodialysis or GFR \<30 mL/min or creatinine level >2.5mg/dL.
Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
Evidence or history of aneurysmal target vessel within the past 2 months.
History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
History of heparin-induced thrombocytopenia (HIT).
Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 , known coagulopathy, or INR >1.5.
Any thrombolytic therapy within 2 weeks of the index procedure.
Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the Wolverine into the subject.
Subjects or their legal guardians who have not or will not sign the Informed Consent.
Subjects who are unwilling or unable to comply with the follow-up study requirements.
Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 4 participants (actual)

Study arms

Experimental
Wolverine System
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
Device: Wolverine System to perform atherectomy

Interventions

DeviceWolverine System to perform atherectomy

What researchers measure

Primary outcomes

Number of Participants With no Major Adverse Events
Freedom from major adverse events (MAE) through 30 day follow-up: * Clinically driven target lesion revascularization (TLR) * Myocardial infarct (MI) * Cardiovascular related deaths * Unplanned, major index limb amputation * Device Related Events: * Clinically Significant Perforations * Clinically Significant Dissections * Clinically Significant Embolus * Pseudoaneurysm
Time frame: Through 30 day follow-up

Secondary outcomes

Technical Success: Percent of Target Lesions That Have a Residual Diameter Stenosis < 50%
Technical success is defined as the percent of target lesions that has a residual diameter stenosis \< 50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate
Time frame: During interventional procedure
Procedural Success: Percent of Target Lesions That Have Residual Diameter Stenosis ≤30% Post-Wolverine and Any Other Adjunctive Therapy
Time frame: Day 0
Number of Participants With no Procedural Emboli
A procedural emboli is defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator.
Time frame: During interventional procedure
Ankle-Brachial Index (ABI) at 30 Days
Ankle-Brachial Index (ABI) is the ratio of blood pressure in the lower legs to the blood pressure in the arms. It is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. ABI \< 0.95 indicates arterial disease; ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease); ABI \> 1.3 is abnormal, and suggests calcification of the artery walls and incompressible vessels, indicating severe peripheral vascular disease.
Time frame: At 30 days
Rutherford Classification at 30 Days Post-procedure
Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: Asymptomatic, to Class 6: Major Tissue Loss. A lower score is less severe disease and a higher score is more severe disease progression.
Time frame: At 30 days

Results

Posted Apr 21, 2021

Participant flow

Participant flow — Overall Study
Milestone	Wolverine System
Started	4
Completed	4
Not completed	0

Outcome measures

PrimaryNumber of Participants With no Major Adverse Events

Freedom from major adverse events (MAE) through 30 day follow-up: * Clinically driven target lesion revascularization (TLR) * Myocardial infarct (MI) * Cardiovascular related deaths * Unplanned, major index limb amputation * Device Related Events: * Clinically Significant Perforations * Clinically Significant Dissections * Clinically Significant Embolus * Pseudoaneurysm

Time frame:: Through 30 day follow-up
Reported as:: Count of participants · Participants

Number of Participants With no Major Adverse Events
Participants	Wolverine System
Number of Participants With no Major Adverse Events	4

SecondaryTechnical Success: Percent of Target Lesions That Have a Residual Diameter Stenosis < 50%

Technical success is defined as the percent of target lesions that has a residual diameter stenosis \< 50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate

Time frame:: During interventional procedure
Reported as:: Number · Percentage of target lesions

Technical Success: Percent of Target Lesions That Have a Residual Diameter Stenosis < 50%
Percentage of target lesions	Wolverine System
Technical Success: Percent of Target Lesions That Have a Residual Diameter Stenosis < 50%	100

SecondaryProcedural Success: Percent of Target Lesions That Have Residual Diameter Stenosis ≤30% Post-Wolverine and Any Other Adjunctive Therapy

Time frame:: Day 0
Reported as:: Number · Percentage of target lesions

Procedural Success: Percent of Target Lesions That Have Residual Diameter Stenosis ≤30% Post-Wolverine and Any Other Adjunctive Therapy
Percentage of target lesions	Wolverine System
Procedural Success: Percent of Target Lesions That Have Residual Diameter Stenosis ≤30% Post-Wolverine and Any Other Adjunctive Therapy	100

SecondaryNumber of Participants With no Procedural Emboli

A procedural emboli is defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator.

Time frame:: During interventional procedure
Reported as:: Count of participants · Participants

Number of Participants With no Procedural Emboli
Participants	Wolverine System
Number of Participants With no Procedural Emboli	4

SecondaryAnkle-Brachial Index (ABI) at 30 Days

Ankle-Brachial Index (ABI) is the ratio of blood pressure in the lower legs to the blood pressure in the arms. It is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. ABI \< 0.95 indicates arterial disease; ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease); ABI \> 1.3 is abnormal, and suggests calcification of the artery walls and incompressible vessels, indicating severe peripheral vascular disease.

Time frame:: At 30 days
Reported as:: Mean · Ratio

Ankle-Brachial Index (ABI) at 30 Days
Ratio	Wolverine System
Ankle-Brachial Index (ABI) at 30 Days	1.32 ± 0.85

SecondaryRutherford Classification at 30 Days Post-procedure

Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: Asymptomatic, to Class 6: Major Tissue Loss. A lower score is less severe disease and a higher score is more severe disease progression.

Time frame:: At 30 days
Reported as:: Mean · score on a scale

Rutherford Classification at 30 Days Post-procedure
score on a scale	Wolverine System
Rutherford Classification at 30 Days Post-procedure	2.6 ± 0.63

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Wolverine System	—	2/4 (50%)	0/4 (0%)

Most frequent serious events

Most frequent serious events
Event	Wolverine System
DissectionVascular disorders	2/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Wolverine System
<=18 years	0
Between 18 and 65 years	2
>=65 years	2

Sex: Female, Male
Sex: Female, Male(Participants)	Wolverine System
Female	1
Male	3

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Wolverine System
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	4
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Wolverine System
Colombia	4

Target lesion length in cm
Target lesion length in cm(cm)	Wolverine System
Mean	8.5 ± 1.7

Vessel Luminal diameter in cm
Vessel Luminal diameter in cm(cm)	Wolverine System
Mean	3.8 ± 0.65

Study locations

2 sites

Angiografia de Occidente
Cali, VAC, Colombia
Clinical Cardiovascular
Medellin, Colombia

Registry details

Key details

Study ID: NCT01775410
Lead sponsor: Avinger, Inc.
Responsible party: Sponsor
First posted: Jan 25, 2013
Start date: Feb 2013
Primary completion: Aug 2013
Completion: Aug 27, 2013
Results posted: Apr 21, 2021
Last update: Apr 21, 2021

Study contacts

John B Simpson, MD

study director · Avinger, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Avinger, Inc.

Start the discussion